New clinical research shows that a noninvasive test, the Breast
Biophysical Examination (BBE), may help physicians more effectively
detect breast cancer, as well as identify women who do not have
cancer. The research, funded in part by the National Cancer Institute,
was presented at the 17th Annual San Antonio Breast Cancer Symposium.

"These studies indicate that the BBE has the potential to
help physicians more effectively diagnose breast cancer,"
says Joseph P. Crowe, Jr., MD, Director of Breast Services at
The Cleveland Clinic Foundation, and the study's lead investigator.

Each year, physical examination and mammography identify suspicious
lesions in millions of women, the vast majority of whom do not
have cancer. Yet many of these women will undergo an extensive
diagnostic workup involving multiple tests, such as diagnostic
mammography or fine needle aspiration. The next step for many
of these women is surgical biopsy, which can cost up to $4,500
per procedure. According to the National Cancer Institute, 182,000
new breast cancers will be diagnosed in 1995 from an estimated
750,000 surgical biopsies.

"Most of the abnormalities found through screening are benign,"
notes Dr. Crowe. "Therefore, an important criterion for any
new diagnostic test is that it accurately identify those patients
who do not have cancer. In this way, additional diagnostic
tests, and open biopsy, can be reserved for those patients most
likely to benefit. This would improve the efficiency of the diagnostic
process, and also significantly decrease the number of unnecessary
biopsies."

The BBE technology is based on the fact that all cells have electrical
charges; however, cancerous tissue contains cells that have different
electrical properties than benign or normal tissue. The BBE noninvasively
measures the electrical differentials between cancerous and benign
tissue using specially designed sensors placed on the skin.

Dr. Crowe presented data on 457 women who participated in the
research. Of these, 392 had breast lesions previously detected
through physical examination or mammography, and were already
scheduled for surgical biopsy. These patients were tested with
the BBE device before going to biopsy. In order to study the test
in women believed not to have breast cancer, an additional 65
patients who had no previously identified lesions were also included
in the study. They were tested using the BBE, but no biopsy was
performed subsequently.

The combined results of the two studies presented by Dr. Crowe
demonstrated 98% sensitivity, identifying cancer in 178 of the
182 patients with cancer; and 86% specificity, indicating no cancer
at all in 181 of the 210 patients without cancer.

"The results of our study indicate that the BBE could be
an important tool in breast cancer diagnosis. It is simple to
administer, does not involve x-rays or image interpretation, and
provides an objective result in approximately 20 minutes. Additionally,
this technology may have the potential in the future to be used
as a screening test," adds Dr. Crowe.

The BBE device is being developed by Biofield Corp. of Roswell,
Georgia.

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